The loving connection between a mother and her baby is a special bonding that can benefit the baby not only in the present, but also well into the future. Bonding brings the mother and child closer together, and this positive attachment can enhance the baby's well-being and later development. Because a healthy bond between the mother and her newborn infant is crucial to the proper development of the child, loving efforts to strengthen that bond are highly valued. Some of the ways in which a healthy mother can show love for her child and promote this bonding is by experiencing joy at her child's smile and by providing appropriate attention to her child's needs.
It has been estimated that over 700,000 mothers are afflicted with postpartum depression (PPD) each year in the United States. PPD is considered to be a major depression, and is characterized by standard depressive features. Typical PPD symptoms include non-responsiveness towards the infant's needs and an absence of joy that is normally associated with healthy parent-child interaction and attachment. Because the first months of life are a critical period for an infant's proper cognitive and emotional development, the lack of attachment and attention towards the infant shown by the PPD mother may cause undesired effects in the child's future behaviors.
During pregnancy, the hormonal balance in the healthy expectant mother is such that she experiences extremely high levels of estrogen throughout her body. These levels of estrogen in the expectant mother may be up to 100 times the normal level. After the birth of the child, the estrogen level in the new mother rapidly decreases over the course of a few days and returns to the normal level of estrogen. Estrogen has been found to be critical to many normal neuronal processes, and has been positively associated with serotonin levels in the brain and brain plasticity. Therefore, and without wishing to be tied to a theory, it is believed that PPD may be caused by an extra-sensitive response in a subset of new mothers to the rapid withdrawal of estrogen from the mother's system.
Antidepressants are often one of the first lines of therapy against PPD. Conventional antidepressants such as tricyclics and selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed for PPD. However, there are many problems associated with the use of these conventional antidepressants for PPD. First, these conventional antidepressants typically alleviate the PPD condition in no more than about 80% of the patients taking them. Second, even when successful, these conventional antidepressants typically take up to 8 weeks be effective. Third, the PPD mother can expect to experience the typical side effects associated with tricyclics and SSRIs. Side effects associated with tricyclics use include dry mouth, dry nose, blurred vision, decreased gastro-intestinal motility and secretion, leading to. Side effects associated with SSRI use include insomnia, weight gain and sexual dysfunction.
In addition, it has been found that virtually all of these conventional antidepressants are found in the mother's milk, and may be transferred to the infant during nursing. There has been little data on the effect of the nursing mother's antidepressant use upon the child's mental development. Rather than demonstrating safety, the literature appears to conclude that the risk to the nursing child posed by the mother's antidepressant use is outweighed by the risks associated with untreated PPD. However, in some cases, the transfer of some particular antidepressants to mother's milk has been so significant that some investigators have concluded that those particular antidepressants should be avoided by nursing mothers.
Sertraline (Zoloft) and paroxetine (Paxil) are the first-line antidepressants for treating PPD (Berle, Curr. Womens Health Rev. 2011 February; 7(1):28-34). No long term studies on the effects of these antidepressants on infants who receive their mother's milk.
In human blood, sertraline is 95% bound to a protein called orosomucoid. Sekar, “Pharmacokinetic interaction between darunavir (TMC114), a new protease inhibitor, and the selective serotonin reuptake inhibitors (SSRIs), paroxetine and sertraline”, 8th International Congress on Drug Therapy in HIV Infection, Glasgow, UK, 12-16 Nov. 2006. In mother's milk, the orosomucoid concentration is only about 3% that of the mother's plasma concentration. (Orczyk-Pawilowicz, Breastfeed. Med., 2014 June: 9, 313-9). According to a 2005 Hu Yulan dissertation, “The In Vivo and In Vitro Studies of Drug Milk: Plasma Distribution and Assessing The Risk To Infant”, sertraline is about 80% bound in mother's milk.
Prior art technology used to analyze the concentration of sertraline in mother's milk appears to use liquid-liquid partitioning to remove sertraline from mother's milk, not solid phase filtering. Attempts have been made to reduce transmission of components by filling the nipple of a nipple shield with an insert, such as a fiber insert, including a microbicide to prevent transmission of disease, such as HIV.
U.S. Pat. No. 8,357,117 (Sokal) discloses a nipple shield adapted to filter breast milk by means of a non-woven material impregnated with an active agent such as sodium dodecyl sulphate (SDS). In some embodiments, Sokal at (7, 25-50) discloses adding to the filter a disc containing a flavoring agent to make the taste of a milk/drug solution more acceptable to the infant.
US Patent Publication US 2007-0010760 (Rosenfeld) discloses filters for filtering contaminants out of breast milk. In some embodiments, Rosenfeld at [0073] discloses the use of cationic and anionic resins that adsorb anions and cations.